Essential Principles of GMP Documentation

1. Basic Principles of GMP Documentation Part 1 15

2. Documentation Objectives 1. To review general requirements for documents 2. To review specific requirements for each document 3. To consider current issues applicable to your countries

3. Documentation General Principles – I • Good documentation is an essential part of the QA system • Should exist for all aspects of GMP • Purpose of documentation • Defines specifications and procedures for all materials and methods of manufacture and control • Ensures all personnel know what to do and when to do it • Ensure that authorized persons have all information necessary for release of product 15.1

4. Documentation General Principles – I • Purpose of documentation (cont.) • Ensures documented evidence, traceability, provide records and audit trail for investigation • Ensures availability of data for validation, review and statistical analysis • Design and use • Depends upon manufacturer • Some documents combined into one, sometimes separate 15.1

5. Documentation What is being made? Most of us when attempting a task need some sort of documentation

6. Documentation And if the drawing is wrong!

7. Documentation

8. Documentation Why are documents so important? • Communication • Cost • Audit trail

9. Documentation General Principles – I • Documents should be • designed • prepared • reviewed • distributed with care • Comply with marketing authorization • Design of documentation important 15.2

10. Documentation General Principles – II • Look at the “Style” of the document • Instructions in the imperative • Short sentences preferred to long sentences • Approval of documentation • Approved, signed and dated by appropriate responsible persons • No document should be changed without authorization and approval 15.3

11. Documentation General Principles – III • Contents of documents should be clear (easy to understand) and include, e.g. • Title, nature, objective or purpose • Layout in orderly fashion • Easy to be filled in and checked • Clear and readable – including copies made • No errors if master documents are copied for working documents 15.4

12. Documentation General Principles – IV Documentation control • Regular review of documents • Kept up to date (current) - amended • Superseded documents removed and not used • Distribution and retrieval of documentation • Retention time for superseded documents 15.5

13. Documentation General Principles – V Data entry • Clear, readable and indelible • Design to allow for sufficient space for entries • Changes to entries: • signed, dated and reason given • original entry still readable • Entries at the time of action • All significant actions recorded – traceable 15.6 – 15.8

14. Documentation General Principles – VI Data entry (cont.) • Electronic data processing systems, photographic systems or other reliable means • Systems require SOPs and records • Accuracy of records checked • Authorized persons - access and changes • Password controlled • Entries checked 15.9

15. Documentation General Principles – VII Data entry (cont.) • Batch records stored electronically: • Protected • Back-up transfer, e.g. magnetic tape, microfilm, paper print-outs • Records kept 1 year after expiry date of product • Data readily available during retention period 15.9

16. Documentation Types of Documentation • Labels • Specifications and testing procedures • Master formulae and instructions • Batch processing and batch packaging records • Standard Operating Procedures (SOPs) • Records • Stock control and distribution records • Other documents …

17. Documentation

18. Documentation • Photographs can be documents and part of a herbal identification, provided they are properly authorized and controlled

19. Documentation • Flow charts provide substantial information at a glance

20. Documentation Types of Documentation • The different types of documents will be discussed in detail in Documentation: Part 2